Santarus Company Profile

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SANTARUS has three approved drugs.

There is one US patent protecting SANTARUS drugs.

There are twenty-three patent family members on SANTARUS drugs in fourteen countries and sixty-seven supplementary protection certificates in fifteen countries.

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	AB3	RX	Yes	Yes	7,780,987	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	6,635,280	⤷ Try a Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	6,488,962	⤷ Try a Trial
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009	6,489,346	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Powder for Oral Suspension	40 mg/1680 mg per packet	➤ Subscribe	2007-08-24
➤ Subscribe	Extended-release Tablets	500 mg and 1000 mg	➤ Subscribe	2009-07-27
➤ Subscribe	Capsules	20 mg/1100 mg and 40 mg/1100 mg	➤ Subscribe	2007-04-30
➤ Subscribe	Powder for Oral Suspension	20mg/1680mg per packet	➤ Subscribe	2007-11-13

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Country	Patent Number	Estimated Expiration
New Zealand	535455	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2010064126	⤷ Try a Trial
Japan	2005526043	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0124495	SPC/GB01/006	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1412357	PA2008013	Lithuania	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1506211	C 2014 029	Romania	⤷ Try a Trial	PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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